Last updated on July 2018

Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry


Brief description of study

The purpose of this registry is to collect additional information regarding the side effects and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). Information will be collected on serious events that are not that common or may only be seen with long-term treatment. These events include death, cancers, serious infections and other infections of interest, and serious mental health problems. Information on the effectiveness of BENLYSTA will also be collected.

Detailed Study Description

The registry will enroll 2 groups of patients. One group will include patients who are currently taking lupus medicines along with BENLYSTA (With BENLYSTA). The other group will include patients who are taking lupus medicines but do not take BENLYSTA (Without BENLYSTA). For every 3 participants enrolled in the registry, 2 will be taking BENLYSTA and 1 will not. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all patients will continue to be followed regardless of changes in their lupus medicines until study completion. Physicians will manage the patient in accordance with their medical judgment and standard of care. Data will be collected at enrollment and at 6 month intervals for 5 years.

Clinical Study Identifier: NCT01729455

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